Genentech, Inc.

F. Hoffmann-la Roche Ag

Thomas W Patapoff

Yajun Wang

Vikas K Sharma

Liangyi Zhang

Dell Farnan

Daniel McDonald

George Tony Moreno

Boyan Zhang

Trevor E Swartz

Ann L Daugherty

Yatin Gokarn

Isidro E Zarraga

Jonathan Zarzar

Randy J Mrsny

Christine Wurth

Apparatus, systems, computer-readable media, articles of manufacture and methods for selecting an antibody. Apparatus, systems, computer-readable media, articles of manufacture and methods for producing the selected antibody. The selecting may include determining one or more physiochemical characteristics of the antibody. The determining may be based on antibody structural parameters.

Antibody selection apparatus and methods

The present invention provides methods for determining chromatography separation conditions; for example, separation of a polypeptide and its charge variants. The invention also provides methods to determine a buffer condition for chromatography separation conditions. The invention also provides a robust method to analyze multiple polypeptide products.

Elucidation of ion exchange chromatography input optimization

The present invention provides methods for analyzing compositions of polypeptides such as antibodies by ionic strength-mediated pH gradient ion exchange chromatography. In some aspects, the methods use a combination of pH gradients and ionic strength gradients to separate the polypeptide from charge variants of the polypeptide. In some aspects, the methods use a stable ionic strength to optimize the pH gradient separation window to separate the polypeptide from charge variants. Such methods are useful for analyzing polypeptide, e.g. antibodies, with a pI greater than 9 or a pI less than 7. In some aspects, the invention provides a multiproduct method for the analysis of polypeptides of varying pI's.

Ionic strength-mediated pH gradient ion exchange chromatography

The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

Antibody formulations

A compaction assay measuring the viscoelasticity of sputum samples of patients subject to respiratory disease is provided. This assay is useful in determining the therapeutic efficacy of DNase, antibiotic and other respiratory disease treatments in improving lung function.

Compaction assay for assessment of respiratory disease therapy

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San Carlos, CA, United States of America

Thomas W Patapoff